In this newsletter

Limited Time: Read about Pragmatic Clinical Trials

A special series of articles addressing the ethical and regulatory challenges to pragmatic clinical trials is available on the website of the journal Clinical Trials only until November 15, 2015. The 12 articles were sponsored by the NIH Health Care Systems Research Collaboratory with additional support from the Patient-Centered Outcomes Research Institute, and include authors drawn from the fields of clinical research and patient advocacy, as well as clinicians, bioethicists, and regulatory experts.Learn more about the seriesRead the articles

Proposed Changes to the Common Rule

On September 2, 2015, the U.S. Department of Health and Human Services issued a proposed overhaul of the Common Rule (45 CFR part 46). Proposed updates include

Improving informed consent by increasing transparency and by imposing stricter new requirements.

Generally requiring informed consent for the use of stored biospecimens in secondary research.

Excluding from coverage under the Common Rule certain categories of activities that should be deemed not to be research, that are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated (and adding categories of exempt research).

Changing the conditions and requirements for waiver or alteration of consent.
And more…

New Studies Seeking Sites

Iodinated Contrast Media (ICM) Study (Pediatrics)

Thyroid Function Testing Following Iodinated Contrast Media Administration.
This study will enroll patients up to 3 years of age who are scheduled to undergo a radiologic procedure requiring iodinated contrast media. Thyroid function tests (TFTs) will be obtained prior to the procedure, and within one week after the procedure. Patients with abnormal TFTs will be followed for 1 year.ClinicalTrials.gov Identifier: TBDContact:
Barrie Harper MT (ASCP), PMPbarrie.harper@duke.edu
919-668-8291Site feasibility survey

Furosemide (Pediatrics)

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
This is a multi-center, randomized, placebo-controlled, dose escalating, double masked, safety study in infants < 29 weeks gestational age at birth, receiving positive airway pressure or mechanical ventilation, and 7 to 28 days postnatal age at time of first study dose.ClinicalTrials.gov Identifier: NCT02527798Sponsor: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Contact:
Mika Pollackmika.pollack@duke.edu
919.668.8741

Visit the DCRI Community website for a current list of DCRI studies recruiting sites.

NIH Collaboratory/PCORnet Grand Rounds
Grand Rounds is a weekly webinar hosted by the NIH Health Care Systems Research Collaboratory and PCORnet.Visit the Grand Rounds portal page to see upcoming presentations and view the video and slide archives.

How to stay connected to the DCRI

Going to AHA?

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